Lead global regulatory strategy for BD medical devices and software, applying regulatory expertise, technical files, and impact assessments in Mississauga.
The Staff Specialist, Regulatory Affairs supports MMS Dispensing products across new product development, sustaining, and end of life activities. Reporting to the Senior Manager, this role addresses U.S. and worldwide requirements, including FDA Medical Device Regulations and EU-MDR. The position combines regulatory strategy, submissions, quality systems, and cross-functional collaboration.
Key Responsibilities:
- Develop global regulatory strategy for dispensing products and software
- Lead compliance with FDA regulations and EU-MDR
- Execute technical file creation and remediation
- Prepare regulatory impact assessments for design changes
- Resolve issues and communicate responses to internal customers
Requirements:
- Bachelor's degree in biology, engineering, or related science
- Five to seven years of medical device regulatory experience
- Software as a Medical Device focus strongly preferred
- Regulatory strategy and submission management skills
- Strong communication, organization, and collaboration abilities
Bring global medical device compliance, software knowledge, and regulatory strategy skills to BD's MMS Dispensing portfolio.
Global Medical Device Regulatory Affairs Specialist in Mississauga employer: Becton, Dickinson and Company
At BD, we are committed to fostering a dynamic work culture that prioritizes collaboration, innovation, and personal growth. As a Territory Manager in the Non-Acute sector, you will have the opportunity to make a meaningful impact in healthcare while enjoying a competitive compensation package and comprehensive benefits. Our remote work flexibility allows you to thrive in your role while maintaining a healthy work-life balance, all within a supportive environment that values your contributions and encourages professional development.
Contact Details:
Becton, Dickinson and Company Recruitment Team
